Embodiments of the present invention relate to the field minimally invasive surgical medical devices and medical procedures. More specifically, embodiments of the present invention relate to devices and methods used for transcervical gynecological procedures.
Female contraception and sterilization may be affected by transervically introducing an object into a fallopian tube to inhibit conception. Devices, systems and methods for such a contraceptive approach have been described in various patents and patent applications assigned to the present assignee. For example, U.S. Pat. Nos. 6,526,979, 6,634,361, U.S. patent application Ser. No. 11/165,733 published as U.S. Publication No. 2006/0293560 and U.S. patent application Ser. No. 12/605,304 describe transcervically inserting an insert (also referred to as implant and device) into an ostium of a fallopian tube and mechanically anchoring the insert within the fallopian tube. One example of such an assembly is known as “Essure”® from Conceptus, Inc. of Mountain View, Calif. Tissue in-growth into the “Essure”® insert provides long-term contraception and/or permanent sterilization without the need for surgical procedures.
The insert may be delivered to the fallopian tube with a delivery catheter assembly such as the one illustrated in FIG. 1. The delivery catheter assembly 100 is formed of a control device 102 such as a handle, an elongated sheath 104, and an insert 106. The delivery catheter assembly 100 may be transcervically positioned into the uterus and the fallopian tubes via a hysteroscope system.
Referring to FIG. 2 the hysteroscope system 200 may include a working channel 202 into which the delivery catheter assembly is inserted. Advancement of the delivery catheter system within the uterus and the fallopian tubes is usually facilitated by distending the uterus with a distention fluid, such as saline, and viewing the placement with the hysteroscope system. A valve clamp 208, such as a ball valve clamp, and an access port 206 are positioned at the tip of the working channel 202. Closing the valve clamp 208 may seal the entrance of the working channel 202 to prevent a distention fluid from leaking out of the access port 206. A sealing cap 230 including a pierceable end 232 can be placed over the access port 206 to prevent distention fluid from leaking out of the hysteroscope system when a delivery catheter assembly occupies the working channel of the hysteroscope system.
An introducer 220 may be used in order to prevent damaging the tip the elongated sheath 104 or insert 106 of the delivery catheter assembly 100 during insertion through the pierceable end 232 of the sealing cap 230 and access port 206, and into the working channel 202 of the hysteroscope system 200. Introducer 220 includes a sheath portion 222 and slit opening 224 to aid in grasping and in the removal of the introducer 220. The introducer 220 is inserted through the pierceable end 232 of the sealing cap 230 and into the working channel 202 prior to inserting the delivery catheter assembly 100. When the introducer 220 is inserted through the sealing cap 230, fluid can spray out of the introducer 220 and onto the physician or physician's assistant. The amount of fluid spray-back can be significant depending on the distention fluid pressure during the procedure.
Referring to FIG. 3, after placing the introducer 220 into the working channel 202, the tip of delivery catheter assembly 100 is inserted into the slit opening 224 and through the sheath 222 of the introducer 220 in order to advance the delivery catheter assembly 100 into the working channel 202 of the hysteroscope system. This is typically performed as soon as possible after placement of the introducer 220 into the working channel 202 in order to minimize the amount of fluid spray-back from the introducer. The introducer 220 may then be removed or may be kept in place throughout the procedure. After insertion of the delivery catheter assembly 100 into the introducer 200, an amount of distention fluid may still leak from between the introducer and elongated sheath 104 of the delivery catheter assembly 100.